Staburo @ workshop from IBS-DR working group “Non-Clinical Statistics”

Staburo recently took part at the workshop of the IBS-DR (Internationale Biometrische Gesellschaft – Deutsche Region) working group “Non-Clinical Statistics”. The workshop was held as hybrid event: Online and at the same time in Ingelheim on 24 and 25 November 2022. It covered many exciting topics in the field of non-clinical statistics like toxicology, design of experiments, process, and stability monitoring.

A recurrent scheme has been that presenters provided insights on challenges for statisticians both in their working environment and on a professional level. State-of the art solutions to address questions that arise from the non-clinical research field were discussed and related against the background of common practises, guidelines, and regulations.

Many thanks to the organisers for this exciting workshop. It was a great opportunity to learn and exchange. We are already looking forward to the next workshop in that group!

Staburo also has a strong focus on non-clinical statistics. We interact with regulatory authorities, and we know and work according to their guidelines on a daily basis. Companies that want to progress non-clinical projects, and medical device companies within an increasingly regulated environment, can benefit from our experience, such as:

• Statistical and analysis planning for medical device trials
• Design of Experiments statistical input and recommendations
• Stability testing
• Dissolution testing
• JoS
• FDS
• Interaction with authorities (e.g. FDA, EMA) focusing on statistical design or data analyses

Please feel free to contact us at any time!

Movie Night @ Staburo

On a Friday night, 18 Staburo team members, 6 big pizzas, popcorn, a bunch of other snacks, soft drinks, and beer. What could this mean? It was about time for our Staburo team movie night.

Finally, the time had come – some of our colleagues have been waiting for years for this event to happen. Originally it was planned in Friday, 13 (!) March 2020. What happened next is still known to us all.

Ironically, the movie “Twelve Monkeys” had already been selected to be shown that evening in early 2020. The movie “Twelve Monkeys” is an American science fiction film, already published in the year 1995 and tells the story about a prisoner who goes back in time to avert a deadly plague.

For this evening, our big meeting room was equipped with all comfortable armchairs and sofas we could find in our office. Around 6pm the group started with food, drinks and even a small presentation from one of our team members. He prepared an entertaining presentation about the main characters of the movie.

Thanks to the organiser for the amazing movie night and the great catering.

Solidarity and fun are not only part our core values, also something that is lived at Staburo and our team enjoys it very much. Thus, quite a few other team events – organised internally by team members, for example a running dinner night or climbing & skiing activities – already happened or are in the making.

We are looking forward to the next team activities!

Staburo @ Statistical Colloquium of FU Berlin

Staburo Managing Director Hannes Buchner will give a talk about “Applied Biomarker analyses in drug development. Lasso, random forest, longitudinal biomarker analyses” at the colloquium “Statistische Methoden in der empirischen Forschung” (“Statistical methods in empirical research”) at the Freie Universität Berlin on February 14, 2023.

The presentation is a collaboration of our Staburo employees Laura Schlieker, Armin Ott, Stephan Bischofberger and Gabriele Bleckert and will provide insight into how random forests, LASSO and IPF-LASSO (Integrated LASSO with Penalty Factors) can be applied to investigate the prognostic and predictive potential of high dimensional biomarker data by using training and test data principles, subsampling methods and permutation concepts. In addition, the application of mixed models with repeated measurements and the concept of sliding regression for analyses of longitudinal biomarker data and their pharmacodynamic features will be addressed.

At the colloquium, which is organised by a committee of members of various institutions and companies, such as Pfizer, Bayer, Parexel and Cytel, speakers from academia and industry present current topics in biostatistics, medicine, epidemiology, agriculture, or other fields of application once a week. It is open to the public and all those interested in empirical research and statistical research are welcome to attend in person or virtually! More information can be found on the institute’s website.

We look forward to numerous listeners and to welcome you within the audience!

Photoshooting @ Staburo

After we published our new company logo recently, it was also time for an update of our company pictures, which were taken by a professional photographer.

Since Staburo is continuously growing and the management team became bigger, we are very proud to also represent this on our website. In addition to our three founders and Managing Directors (Höfler, Stieger, Buchner), we do have two heads and six directors, who we are very happy to be in the spotlight since their designation.

Therefore, we also started a mini-series about each new management team member in our news section (available direct links: Bentink, Böhm, Esmaeili, Frank, Herich, Husfeld, Roy, Schlieker).

Additionally, our office spaces have been filled with more life, i.e., new furniture, plants, and colors over the last months.

We are very happy to share the new pictures of our entire management team and give you an impression of the atmosphere in our office. We hope you enjoy exploring our new pictures and our updated website!

Staburo @ workshop from IBS-DR working group Pharmaceutical Research (APF)

As usual, Staburo took part in the annual workshop of the APF (working group Pharmaceutical Research, of the International Biometric Society German Region) in Berlin on 25 November 2022. After two virtual APF workshops in 2020 and 2021 due to the pandemic situation, this year’s workshop finally took place again as a face-to-face meeting. The get-together evening event on 24 November was hosted by Cytel and it was a great opportunity to meet and discuss with other participants.

This year, the workshop had two parts. The topic of the morning session was “Planning and Estimands for Safety/Benefit-Risk”. The first two talks were about Aggregated Safety Assessment Planning and the trend to move away from isolated safety analyses and single-case evaluation toward benefit-risk assessment planning and a more quantitative approach based on frequency analysis. Other presentations were dealing with safety endpoints for HTA and with the question of what needs to be considered for building an estimand framework for safety.

The afternoon session was dedicated to the topic of “External and Synthetic Control Arms”. Attendees were first introduced to the subject with an overview of the benefits and pitfalls of external data as controls in clinical trials and strategies that can be applied when using external data. This was followed by talks about how multistate models can mitigate the problem of small sample sizes by borrowing information from external control data, and about synthetic control arms in regulatory and HTA assessments.

Many thanks for the great organisation. It was a great workshop, and we are already looking forward to 2023!